BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1862042 · Received October 8, 2010

    Report

    Report Number
    2134265-2010-04436
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    June 29, 2010
    Report Date
    September 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT MOVED DISTALLY ON THE BALLOON, SO THAT THE PROXIMAL EDGE OF THE STENT WAS 32MM DISTAL TO THE PROXIMAL MARKERBAND. THE STENT WAS SLIGHTLY EXPANDED THROUGHOUT AND THE STENT STRUTS WERE DAMAGED. AT THE PROXIMAL END ROWS ONE AND TWO WERE RAISED DISTALLY. THREE ROWS OF STRUTS IN THE MIDDLE OF STENT WERE MISALIGNED. THE REMAINDER OF THE MIDDLE SECTION OF THE STRUTS WAS SLIGHTLY EXPANDED AT THE DISTAL EDGE. THE BALLOON WAS FOUND TO HAVE THE STENT IMPRESSION ON IT AND PILLOWING OF THE BALLOON INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. THERE WAS NO DAMAGE TO THE SHAFT OF THE STENT DELIVERY SYSTEM (SDS). THE BALLOON AND TIP SECTIONS OF THE DEVICE WERE VISUALLY AND MICROSCOPICALLY EXAMINED AND NO ISSUES WERE NOTED WITH THEIR PROFILES THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. A 0.015 INCH PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED (B)(6) 2010. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, THE STENT WOULD NOT CROSS THE LESION. THE TARGET LESION WAS HIGHLY CALCIFIED LOCATED IN THE RIGHT CORONARY ARTERY (RCA). DURING THE PROCEDURE, THE PHYSICIAN COULD NOT CROSS A 3.5X38MM TAXUS LIBERTE STENT TO THE TARGET LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE. ANALYSIS OF THE RETURNED DEVICE REVEALED THE STENT MOVED ON THE BALLOON AND STENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493893638350 0012831541

    Patients

    Seq Age Sex Outcome Treatment
    1